UroGen Pharma has received the new drug application (NDA) acceptance from the US Food and Drug Administration (FDA) for UGN-102 (mitomycin) for intravesical [directly into the bladder] administration to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

UGN-102 is a drug formulation of mitomycin and uses UroGen's RTGel technology.

The technology allows for a sustained release, hydrogel-based formulation with reverse-thermal properties.

The investigational drug UGN-102 is designed to prolong bladder tissue's exposure to mitomycin, facilitating non-surgical tumour treatment.

Bladder cancer is the second most common urologic cancer in men in the US, primarily affecting the older population.

UroGen president and CEO Liz Barrett said: "The FDA acceptance of our NDA is a pivotal moment in our journey to bring UGN-102 to patients.

“UGN-102 could be the first FDA-approved medicine for LG-IR-NMIBC, offering a novel approach that could expand treatment options and address unmet needs. There is an urgent need for innovative solutions in this space, and we are dedicated to collaborating with the FDA as we prepare for a potential launch of UGN-102 in 2025.”

The NDA submission is supported by data illustrating the durability of response from three clinical trials, highlighting the drug’s safety profile.

The Phase III multinational, single-arm, multicentre ENVISION study, met its primary endpoint with a 79.6% complete response rate three months after the first UGN-102 instillation.

Further results from the study showcased an 82.3% 12-month duration of response as determined by the Kaplan-Meier estimate in subjects with complete response (CR) at three months.

The safety profile of UGN-102 was consistent with other studies of the drug.

With the FDA's assignment of a Prescription Drug User Fee Act (PDUFA) date of 13 June 2025, the NDA for UGN-102 is currently under review. A decision is anticipated by that date.